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Claims for Patent: 6,126,968

Claims for Patent: 6,126,968

Title:

Stable compositions containing N-propargyl-1-aminoindan

Abstract:

A pharmaceutical composition comprising as active ingredient a racemic, S(-), and R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least 60% by weight of at least one pentahydric or hexahydric alcohol. Optionally the composition may contain citric acid and magnesium stearate.

Inventor(s):

Peskin; Tirtsah Berger (Raanana, IL), Caciularu; Fanny (Tikva, IL)

Assignee:

Teva Pharmaceutical Industries, Ltd. (Jerusalem, IL)

Application Number:

09/043,475

Patent Claims:

1. A pharmaceutical composition in tablet form comprising as an active ingredient a therapeutically effective amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically
acceptable salt thereof, and at least one alcohol selected from the group consisting of pentahydric and hexahydric alcohols.

2. The pharmaceutical composition of claim 1, wherein said at least one alcohol comprises at least 60% by weight of the total composition.

3. The pharmaceutical composition of claim 1, wherein the alcohol is selected from the group consisting of mannitol, xylitol and sorbitol.

7. The pharmaceutical composition of claim 5, wherein the amount of magnesium stearate is 0.1 to 0.5% by weight of the total composition.

8. The pharmaceutical composition of claim 1, in which the amount of said at least one alcohol is between 60% and 70% of the total composition, and further comprising citric acid.

9. The pharmaceutical composition of claim 1, wherein said active ingredient is R(+)-N-propargyl-1-aminoindan.

10. A pharmaceutical composition in tablet form comprising as an active ingredient a therapeutically effective amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least 75% by weight of at least one
alcohol selected from the group consisting of mannitol, xylitol and sorbitol.

11. The pharmaceutical composition of claim 10, wherein the amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof is 3.0% or less by weight of the composition, and wherein the alcohol at least 75% by weight of the
composition.

12. The pharmaceutical composition of claims, wherein the alcohol is mannitol.

13. A pharmaceutical composition comprising as an active ingredient a therapeutically effective amount of R(+)-N- propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least one alcohol selected from the group consisting
of pentahydric and hexahydric alcohols.

14. The pharmaceutical composition of claim 13, wherein said at least one alcohol comprises at least 60% by weight of the total composition.

15. The pharmaceutical composition of claim 13, wherein, the alcohol is selected from the group consisting of mannitol, xylitol and sorbitol.

19. The pharmaceutical composition of claim 18, wherein the amount of magnesium stearate is 0.1 to 0.5% by weight of the total composition.

20. The pharmaceutical composition of claim 13, in which the amount of said at least one alcohol is between 60% and 70% of the total composition, and further comprising citric acid.

21. The pharmaceutical composition of claim 13, wherein said active ingredient is R(+)-N-propargyl-1-aminoindan.

22. A pharmaceutical composition comprising as an active ingredient a therapeutically effective amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least 75% by weight of at least one alcohol selected
from the group consisting of mannitol, xylitol and sorbitol.

23. The pharmaceutical composition of claim 22, wherein the amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof is 3.0% or less by weight of the composition, and wherein the alcohol at least 75% by weight of the
composition.

24. The pharmaceutical composition of claim 23, wherein the alcohol is mannitol.

25. The pharmaceutical composition of claim 2, wherein the amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof is 3.0% or less by weight of the composition.

26. The pharmaceutical composition of claim 14, wherein the amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof is 3.0% or less by weight of the composition.

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